eligibility_summary
Adults 18-75 with MG (MG-ADL >=6, ocular score <50%) refractory after >=2 conventional immunotherapies, or MG-ADL >=6 persisting >=6 months, or >=2 yearly exacerbations during taper, or crisis with ventilator dependence >14 days despite IVIG/PLEX/high-dose IV steroids, AChR/MuSK/LRP4 Ab positive, consented. Exclude: pregnant/lactating, blinatumomab allergy, recent/planned thymectomy, recent eculizumab/tocilizumab, IVIG/PLEX (<4 wks), other trials. Anti-CD19/20 in past 6 mo allowed if B cells >= LLN.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06684184 (Phase 2/3, single-arm) in refractory myasthenia gravis. Intervention: Blinatumomab, a bispecific T‑cell engager (BiTE) antibody construct, given as continuous IV infusion (two 5‑day cycles separated by 1 week). Mechanism of action: Simultaneously binds CD3 on T cells and CD19 on B‑lineage cells to redirect cytotoxic T cells to kill CD19+ B cells. Targeted cells/pathways: CD19+ B cells (naive, memory, plasmablasts, may spare CD19− long‑lived plasma cells), leading to depletion of autoreactive B cells and reduction of pathogenic autoantibodies (anti‑AChR, anti‑MuSK, anti‑LRP4). Modulates the T cell–B cell axis and attenuates humoral autoimmunity driving NMJ dysfunction. Potential on‑target immune effects include T‑cell activation and cytokine signaling.